GDUFA Research Outcomes

Data & AI

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to data analytics and artificial intelligence (AI) for generic product development and assessment, including the development of natural language processing (NLP) and machine learning (ML) tools

• All(125)
• Posters(29)
• Presentations(37)
• Papers(59)

• The Future of AI and the Generic Drug Community

  Lionberger, Robert

• Leveraging Generative AI (GenAI) to Support Regulatory Assessment

  Hu, Meng

• Generative AI-Powered Regulatory Efficiency and Excellence

  Lee, Jae

• Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling

  Zhao, Liang

• Big Data Application in Life Sciences

  Zhao, Liang

• FDA Scientific Efforts on Investigating Excipient-Drug Interactions

  Zhang, Lei

• Regulatory Science Issues in the Effect of Microbimes on Bioequivalence Determination for Generic Drug Products

  Zhang, Lei

• Developing a Statistical Approach to Facilitate Sameness Assessment of Complex Heterogenous Active Pharmaceutical Ingredients

  Weng, Yu Ting; Hu, Meng; Zhao, Liang; Wang, Chao; Shen, Meiyu; Gong, Xiajing

• Leveraging Large Language Models (LLMs) to Support Regulatory Assessments

  Wang, Jing

• Approaches to Analyzing Comparative Use Human Factors Studies

  Wang, Jing